EP2262432B1 - Systems for surgical removal of tissue - Google Patents

Systems for surgical removal of tissue Download PDF

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Publication number
EP2262432B1
EP2262432B1 EP09720711.2A EP09720711A EP2262432B1 EP 2262432 B1 EP2262432 B1 EP 2262432B1 EP 09720711 A EP09720711 A EP 09720711A EP 2262432 B1 EP2262432 B1 EP 2262432B1
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EP
European Patent Office
Prior art keywords
aspiration
proximal
distal
inner member
window
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP09720711.2A
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German (de)
English (en)
French (fr)
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EP2262432A1 (en
Inventor
Louis M. Shadeck
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Xomed LLC
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Medtronic Xomed LLC
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Publication of EP2262432A1 publication Critical patent/EP2262432A1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A61M1/742—Suction control by changing the size of a vent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • the present disclosure relates to treatment of body tissues. More particularly, it relates to surgical systems, instruments, and methods useful in reducing and/or removing tumorous tissues.
  • Tumors are commonly treated with chemotherapy, radiation, surgery, and other techniques.
  • surgical instruments such as a cavitational ultrasonic surgical aspirator (CUSA) or a surgical laser knife, are commonly used.
  • Brain surgery is the treatment of choice for accessible brain tumors. While a CUSA may be used to treat many tissues other than brain tumors, brain surgery provides a useful example to highlight some of the difficulties arising in the surgical removal of delicate tissues. The goal of surgery is to remove as much tumor tissue as possible. Among other procedures, the most commonly performed surgery for removal of a brain tumor is a craniotomy. In general, the neurosurgeon makes an incision into the scalp, cranium, dura, meninges, and cortex to expose an area of brain over the tumor. Location and removal of the tumor then takes place.
  • the delicate tissues associated with the human brain anatomy give rise to several concerns when using a CUSA, laser knife, or other brain surgery instruments such as cold steel instruments, ultrasonic cutting devices, and bipolar radiofrequency plasma ablation systems.
  • the brain is covered by three membranes or meninges that in turn are surrounded by the skull.
  • the three layers of meninges are the dura mater (immediately beneath the skull), the arachnoid, and the pia mater.
  • Spinal fluid flows in the space between the arachnoid and the pia mater membranes, known as the subarachnoid space.
  • These meninges are thin and delicate, with the pia mater carrying or maintaining the many blood vessels associated with the brain.
  • CUSA instruments deliver ultrasonic action to remove tissue and bone. The surgeon attempts to place the ultrasonic cutting tip against tissue to be destroyed. However, high frequency cutting may also occur and damage tissue surrounding the targeted tumor when touched by the instrument's shaft. Further, due to the relatively large size of the CUSA handpiece, it may be difficult to visually confirm placement of the ultrasonic shaft/tip. Similarly, use of a laser knife may give rise to unintended tissue damage due to local heat in and around the incision line.
  • WO 81&01363 teaches a surgical cutting instrument.
  • Some aspects in accordance with principles of the present disclosure relate to a surgical system and method for surgically treating a tumor or other body tissue of a patient.
  • the system includes a surgical cutting instrument, a motor, and a source of negative pressure.
  • the cutting instrument includes an inner member, an outer member, a handpiece, and an aspiration control mechanism.
  • the inner member includes a distal cutting tip, whereas the outer member has a distal region forming a cutting window and an elevator tip distal the cutting window.
  • the handpiece maintains the inner and outer members such that the inner member is rotatably received within the outer member, with the cutting tip being exteriorly exposed at the cutting window. Further, the cutting tip and the distal region combine to define a cutting implement.
  • the motor is connected to the inner member for moving the inner member relative to the outer member, for example as part of a cutting operation.
  • the system includes a fluid pathway extending from the cutting implement through the handpiece to the source of negative pressure.
  • the aspiration control mechanism is incorporated within the handpiece while in other configurations, the aspiration control mechanism is incorporated within a coupler configured to couple the inner and outer members to the handpiece.
  • the aspiration control mechanism includes a control pathway integrated within an interior of the handpiece or of the coupler to define a segment of the fluid pathway.
  • the aspiration control pathway includes a user interface port exposed on an exterior of the handpiece or the coupler and which is open to the ambient environment. The user interface port provides user control over a level of vacuum (supplied via the remainder of the fluid pathway and the negative pressure source) applied at the cutting implement.
  • the system is configured such that when the source of negative pressure is generating negative pressure and the user interface port is exteriorly unobstructed, a level of vacuum applied at the cutting implement is substantially zero.
  • an opening is created through a skull of the patient to provide external access to a treatment site at which the brain tumor is located.
  • the cutting implement is delivered through the opening to the treatment site.
  • the elevator tip is inserted partially between the target tissue (e.g., the tumor) and the surrounding tissue of the treatment site, such as one or more of dura, arachnoid, pia, and cerebral cortex.
  • the cutting tip is placed into contact with the tumor.
  • the inner member is then moved relative to the outer member, thereby causing the cutting tip to cut tissue of the tumor.
  • the treatment site is selectively aspirated to remove the cut or debrided tumor tissue.
  • methods of the present disclosure further include varying a level of vacuum (or aspiration rate) at the treatment site throughout the procedure, with the tumor being drawn into contact with the cutting tip via applied aspiration prior to a cutting operation.
  • Embodiments of the system also can be employed in removing brain tumors via other access pathways.
  • access to the brain may be obtained through the nose, palate, and oropharnyx to treat tumors such as pituitary tumors, clival cordomas, cholesterol granulomas, neuroesthesioblastomas, skull base meningiomas, and meningoceles.
  • embodiments of the system are applied to treat to tumors via the lateral skull base, such as acoustic neuromas.
  • tumors and/or lesions of the upper and lower airway are treated according to principles of the present disclosure.
  • these types of tumors and/or lesions include those generally occurring on the vocal cords, as well as recurrent respiratory papilloma, cysts, polyps, Reinke's edema or polypoid vocal corditis, benign tumors, and malignant tumors.
  • embodiments of the present disclosure are applicable to treating tumors and/or lesions in the bronchus.
  • the above system is highly useful in performing tumor surgery and other types of surgery.
  • the system affords the neurosurgeon the ability to more precisely effectuate cutting only of the brain tumor, as well as to control aspiration applied to the treatment site.
  • FIG. 1 A surgical system 20 in accordance with aspects of the present disclosure for reducing or removing body tissues is shown in FIG. 1 .
  • system 20 can be used in debriding a brain tumor as part of brain surgery.
  • the system 20 includes a surgical cutting instrument 22, a source of negative pressure 24, and a power source 26. Details on the various components are provided below.
  • the surgical instrument 22 includes a blade assembly 28 forming a cutting implement 30 (referenced generally), a handpiece 32, and an integrated aspiration control mechanism 34 (referenced generally).
  • the source of negative pressure 24 is fluidly connected to the cutting implement 30 via a fluid pathway 36 extending up to and through a housing 38 of the handpiece 32.
  • a proximal region of the handpiece 32 also includes an aspiration passage 37 that partially defines the fluid pathway 36 and which is fluidly connected to the negative pressure source 24 via tubing 47.
  • the power source 26 is electrically connected to a motor (shown in FIG. 7B as motor 202) maintained by the handpiece 32.
  • the cutting implement 30 is deployed to a treatment site, with the user manipulating the handpiece 32 to achieve a desired position of the cutting implement 30 relative to the brain tumor.
  • the power source 26 energizes the motor to effectuate a tumor cutting operation at the cutting implement 30.
  • the aspiration control mechanism 34 is manually operated by the user to selectively effectuate aspiration at the cutting implement 30 via a vacuum generated by the source of negative pressure 24.
  • the aspiration control mechanism 34 includes a user interface port 35 which affords the user the ability to vary the rate or level of aspiration, as well as an aggressiveness of cutting at the cutting implement 30.
  • the surgical instrument 22 includes the blade assembly 28, the handpiece 32, and the aspiration control mechanism 34 as mentioned above.
  • surgical instrument 22 also includes a blade coupler 33 and/or a transition assembly 42.
  • the blade coupler 33 is configured to couple the blade assembly 28 to handpiece 32.
  • the blade coupler 33 includes the aspiration control mechanism 34 as well as a variety of components facilitating control over several functions (e.g., cutting, rotation, etc.) of blade assembly 28.
  • the transition assembly 42 is configured as a distal extension of the housing 38 of handpiece 32 and joins blade coupler 33 to handpiece 32. In some configurations, the transition assembly 42 is omitted with blade coupler 33 being directly connected to the housing 38 of the handpiece 32. While FIGS. 2-7B illustrate blade coupler 33 as positioned separate from (and distal to) housing 38, in yet other configurations, the functions of blade coupler 33 are incorporated within the housing 38 of handpiece 32.
  • control assembly 40 configured to provide user control over a rotational position of a component of the blade assembly 28 as described below.
  • control assembly 40 includes a rotatable wheel 41 configured to actuate a translation mechanism (not shown) within transition assembly 42 (or alternatively within housing 38), which in turn causes rotation of components of the blade assembly 28, as further described later in association with FIGS. 5-7B .
  • the blade assembly 28 can assume a variety of forms, and in some configurations includes an outer member assembly 50 having an outer member 52, and an inner member assembly 54 having an inner member 56.
  • the inner member 56 is rotatably disposed within the outer member 52, with other components of the assemblies 50, 54 defining portions of the blade coupler 33 to effectuate connection to the handpiece 32.
  • the outer and inner members 52, 56 extend distally from the handpiece 32, and combine to form the cutting implement 30 as described below.
  • the blade assembly 28 is shown as including two of the members 52, 56, in other configurations, three or more co-axially assembled members can be provided.
  • the blade assembly 28, and in particular the members 52, 56 can have a linear or straight configuration as shown, or can alternately have a curved construction (such as by the inclusion of a curved member encompassing at least a portion of the outer member 52).
  • the aspiration control mechanism 34 also can assume a variety of forms, and in some configurations forms a part of blade coupler 33 with the user interface port 35 (also shown in Figure 1 ) located distally of handpiece 32, as will be further described in association with Figures 3A and 5-6 .
  • aspiration control mechanism 34 defines an aspiration control pathway 65 ( FIGS. 5-6 ) that forms a segment of fluid pathway 36 between cutting implement 30 and negative pressure source 24.
  • the aspiration control mechanism 34 enables a user to control the amount of aspiration or vacuum at cutting implement 30 via selectively positioning their finger over the user interface port 35 while using the same hand to hold the handpiece 32 in position relative to the treatment site.
  • user interface port 35 enables a comfortable placement of the control finger as it extends forward (and on a side of the handpiece 32) relative to the rest of their hand, which is gripping the handpiece 32.
  • handpiece 32 also includes an aspiration port 39 and a wiring conduit 208.
  • the aspiration port 39 is configured for connection to fluid pathway 36 and negative pressure source 24 (via port 37 and tubing 47 shown in FIG. 1 ).
  • the wiring conduit 208 is configured to route wiring from a motor (shown as motor 202 in FIG. 7B ) and/or other components from the housing 38 of handpiece 32 to power source 26.
  • the outer member assembly 50 includes an aspiration hub 60, an aspiration subassembly 61, a collet 62, an irrigation hub 64.
  • the outer member 52 is secured to the aspiration hub 60, with the collet 62 facilitating attachment to the handpiece 32 as part of blade coupler 33.
  • the irrigation hub 64 facilitates delivery of an irrigation fluid to the outer member 52.
  • the outer member 52 is tubular in some embodiments, and forms a distal region 66.
  • the distal region 66 forms in some configurations a cutting window 70 and an elevator tip 72 distal the cutting window 70.
  • the distal region 66 can be an integrally formed component of the outer member 52, or can be separately formed and assembled to other components (e.g., the distal region 66 can be formed and then attached to an appropriately sized, rigid metal tube in completing the outer member 52). Regardless, one construction of the distal region 66 in accordance with principles of the present disclosure is shown in greater detail in FIG. 4A . As shown in FIG. 4A , the distal region 66 forms a lumen 74 that is otherwise open at the cutting window 70 (and continues proximally through at least a substantial portion of a remainder of the outer member 52 ( FIG. 3A )). With this in mind, the cutting window 70 is defined by a cutting window wall 76.
  • a recessed portion 78 is formed in the distal region 66 about at least a proximal portion of the cutting window wall 76, such that the distal region 66 tapers in wall thickness along the recessed portion 78.
  • the cutting window 70 can have a tear drop-like shape in longitudinal length, decreasing in lateral perimeter width from a distal segment 80 to a proximal segment 82.
  • the elevator tip 72 extends distal the cutting window 70, terminating at a sharpened or blade edge 84. In this regard, the elevator tip 72 is closed relative to the lumen 74. In one embodiment, the elevator tip 74 is defined by opposing, first and second surfaces 86, 88.
  • the distal region 66 can assume a variety of forms, for example, including the forms described in U.S. Patent Application Serial No. 11/938,625, filed November 12, 2007 , and entitled "Systems and Methods For Surgical Removal of Brain Tumors".
  • the elevator tip 72 (e.g., curved surfaces, increased width, and the blade edge 84) combine to provide the elevator tip 72 with a curette-like form.
  • the elevator tip 72 is highly amenable for interfacing with the delicate tissues encountered during brain surgery (as well as other challenging treatment sites).
  • the blade edge 84 promotes partial separation or isolation of tumor tissue from the brain and other normal tissue, with the curved surfaces 86, 88 assisting in isolating or separating the tumor from other tissue.
  • the elevator tip 72 can be eliminated.
  • the distal region 66 can terminate at the cutting window 70 that is otherwise axially and radially open to the lumen 74.
  • the cutting window 70 can be formed in the distal region 66 as a side (or radial) window, with the outer member 52 having a relatively uniform outer diameter distal the cutting window 70.
  • the inner member assembly 54 includes the inner member 56, as well as an inner member hub 100.
  • the inner member hub 100 maintains the inner member 56, and facilitates connection of the inner member assembly 54 (as part of blade coupler 33) to a motor 202 (represented schematically and also shown in FIG. 7B ).
  • the inner member hub 100 can assume a variety of forms.
  • the inner member 56 is tubular, forming a distal cutting tip 102.
  • the inner member 56 also forms a proximal aspiration window 103 exposing access to lumen 105.
  • Proximal aspiration window 103 provides just part of aspiration control mechanism 34 and the fluid pathway 36 that enables fluid communication between the aperture 168 of distal cutting tip 102, user interface port 35, and negative pressure source 24, as further described later in association with Figures 5-6 .
  • proximal aspiration window 103 is shown in FIG. 3A as having a generally rectangular shape, in some other configurations proximal aspiration window 103 can assume other forms such as a circular, elliptical, or polygon shape.
  • proximal aspiration window 103 takes the form of an array 160 of holes 162 arranged in one or more rows along a wall of the inner member 56.
  • proximal aspiration window 103 can take the form of an array 164 of holes 166 arranged in one or more spiral patterns about the wall of the inner member 56. In either case, holes 162, 166 provide a fluid communication path through a proximal portion of the inner member 56, with array 162 or 164 configured to be resistant to occlusion from tissue, fluids or other interferents.
  • the cutting tip 102 can include a series of serrations or teeth 167.
  • the teeth 167 are formed about an aperture 168 that is otherwise open to a lumen 105 defined by the inner member 56.
  • the aperture 168 and the lumen 105 serve as an aspiration outlet of the fluid pathway 36 ( FIG. 1 ) otherwise employed for aspirating a treatment site.
  • the cutting tip 102 can assume other forms that may or may not include an aperture fluidly connected to a lumen.
  • the cutting tip 102 can be a closed burr.
  • fluid pathway 36 ( FIG. 1 ) includes a segment defining an aspiration control pathway 65 ( FIGS. 5-6 ) which establishes fluid communication between user interface port 35 and lumen 105 within inner member 56.
  • aspiration control pathway 65 is defined by several components of blade coupler 33, including aspiration hub 60, aspiration subassembly 61, collet 62, irrigation hub 64, and portions of inner member 56.
  • aspiration hub 60 can assume other forms, in one configuration as shown in FIG. 3A , aspiration hub 60 defines a generally tubular member sized and shaped for slidable insertion within irrigation hub 64 and collet 62, as later shown in FIGS. 5-6 .
  • Aspiration hub 60 includes a distal end 107, a proximal end 108, a distal lumen 120 for receiving outer member 52 (with inner member 56 arranged coaxially therein), and a proximal aspiration chamber 152 (shown in FIGS. 5-6 ). In some constructions and as shown in FIGS.
  • aspiration hub 60 includes a series of grooves 118 extending circumferentially about an outer surface of aspiration hub 60 with the respective grooves 118 being spaced apart from each other along a length of hub 60.
  • An irrigation channel 110 is interposed between a distal one and an intermediate one of the respective grooves 118 while an aspiration channel 112 is interposed between the intermediate one and a proximal one of the respective grooves 118.
  • aspiration channel 112 further defines a hole 122 to provide access to and fluid communication with a proximal aspiration chamber 152 (shown in FIGS. 5-6 ) formed within aspiration hub 60.
  • aspiration hub 60 adjacent proximal end 108, aspiration hub 60 also includes an extension portion 114 and a rotation-engaging mechanism 116 configured to be engaged by a portion of control assembly 40, as further described later in association with FIG. 7A .
  • the rotation-engaging mechanism 116 of aspiration hub 60 is configured to translate rotational motion from the control assembly 40 to cause rotation of outer member 56.
  • seals 130 e.g., O-rings
  • an aspiration subassembly 61 is provided and defines a portion of aspiration control pathway 65 extending within blade coupler 33. While aspiration subassembly 61 can assume a variety of forms, in some configurations, aspiration subassembly 61 comprises a generally tubular shaped sleeve 140 sized and shaped to fit within the proximal aspiration chamber 152 of aspiration hub 60. As shown in FIGS. 3A and 5-6 , the sleeve 140 generally defines a lumen 152 extending between a distal end 153 and a proximal end 154.
  • sleeve 140 further includes a proximal wall region 150 defining a generally continuous wall and a distal window region 158 defining at least one window 156 (two windows 156 are shown in FIG. 3A ) exposing access to lumen 152.
  • irrigation hub 64 further includes one or more seals 142 and a plug 144 arranged to sealingly secure sleeve 140 within aspiration proximal chamber 152 of aspiration hub 60, as further illustrated in association with FIGS. 5-6 .
  • irrigation hub 64 can assume many forms, in some configurations, irrigation hub 64 includes a generally tubular shell defining a lumen 133 extending between a distal end 131 and a proximal end 132.
  • irrigation hub 64 includes an irrigation port 134 and an aspiration aperture 136.
  • the irrigation port 134 is configured for fluid connection to a fluid source (not shown).
  • the aspiration aperture 136 is sized, shaped, and positioned for fluid communication with user interface port 35 of collet 62 and with hole 122 (within aspiration channel 112) of aspiration hub 60, as further illustrated in FIGS. 5-6 .
  • collet 62 of blade coupler 33 defines an outer shell sized and shaped to enclose and cover other components of blade coupler 33, including irrigation hub 64, aspiration hub 60, and aspiration subassembly 61 in their assembled form.
  • collet 62 defines a lumen 63 sized to slidably receive and mount outer member 52.
  • collet 62 holds these components together, enabling each of these components to accomplish their respective functions to support operation of cutting implement 30 at a treatment site.
  • a user can control a level of vacuum at cutting implement 30 ( FIG.
  • FIGS. 5-7A Final construction of the blade assembly 28 and blade coupler 33, which include outer member assembly 50 and inner member assembly 52 is shown in FIGS. 5-7A , with FIGS. 5 and 6 providing cross-sectional views and FIG. 7A providing a perspective view.
  • the outer member 52 is secured via lumen 120 of the aspiration hub 60 (and therefore relative to lumen 63 of collet 62), which is in turn received within the irrigation hub 64.
  • the irrigation hub 64 comprises an inner shell that is slidably inserted and secured within the outer shell defined by collet 62.
  • seals 130 effectuate a fluid-tight seal between the irrigation hub 64 and the aspiration hub 60.
  • an irrigation liquid (not shown) is supplied through port 134 for delivery to the lumen 74 of the outer member 52 via a sealed gap 170 between the respective hubs 60, 64 (as defined by irrigation channel 110) and a bore 109 ( FIGS. 3A and 5 ) formed in a proximal region of the outer member 52.
  • the irrigation channel 110 extends circumferentially about an outer surface of aspiration hub 60 and generally transverse to a longitudinal axis of the aspiration hub 60.
  • the assembled hubs 60, 64 are coaxially received with the collet 62, with the outer member 52 extending distal the collet 62 as shown.
  • Other constructions capable of effectuating flow of irrigation liquid to the outer member 52 are also envisioned; in yet other configurations, the irrigation hub 64 (as well as any other irrigation component) can be eliminated.
  • the aspiration control mechanism 34 can assume a variety of forms, and in some embodiments, defines the aspiration control pathway 65 forming a segment of fluid pathway 36.
  • the sealed, coaxial relationship of the aspiration hub 60 within the irrigation hub 64 also defines a gap 174 between seals 130 (within grooves 118) and the aspiration channel 112.
  • gap 174 is open to user interface port 35 via hole 136 of irrigation hub 64.
  • gap 174 is also open to proximal vacuum chamber 152 of hub 60 via hole 122 in the aspiration channel 112.
  • the aspiration control pathway 65 begins, in one respect, with user interface port 35 of collet 62 ( FIG. 6 ), extends through hole 136 of irrigation hub 64 ( FIG. 6 ), into aspiration channel 174 ( FIG. 5 ) of aspiration hub 60, through hole 122 from the gap 174 defined by aspiration channel 112 ( FIG. 5 ) and down into proximal aspiration chamber 152 of aspiration hub 60 ( FIG. 5 ), into window portion 156 of sleeve 140 (see FIG. 5 and 3A ) and through lumen 152 of sleeve 140 for passage into lumen 105 of inner member 56 via proximal aspiration window 103 ( FIG. 5 ).
  • Aspiration control pathway 65 joins to the rest of fluid pathway 36 via lumen 105 of inner member 56 which extends distally to aperture 168 at distal cutting tip 102 and which extends proximally through inner member hub 100 for passage through an interior of handpiece 32 for connection to negative pressure source 24. More details regarding the aspiration control pathway 65 in relation to the structure of the handpiece 32 are described and illustrated in association with FIG. 7B . Accordingly, in general terms, the aspiration control pathway 65 establishes a segment of the fluid pathway 36 internally within blade coupler 33 (as an extension of handpiece 32) to establish fluid connection between the source of negative pressure 24 to the cutting implement 30 (via lumen 105 of inner member 50). More particularly, in some configurations, the aspiration control mechanism 34 (including its control pathway 65) is configured without an external structure on the housing 38 of handpiece 32, which could otherwise hinder a surgeon's handling of surgical instrument 22.
  • proximal vacuum window 103 of inner member 50 enables an internal path for aspiration control mechanism 34, with proximal wall region 150 of sleeve 140 redirecting the fluid pathway distally into proximal aspiration chamber 152 (of aspiration hub 60) where distal window region 156 of sleeve 140 permits fluid communication between lumen 152 of sleeve 140 and proximal aspiration chamber 152.
  • hole 122 in the aspiration channel 112 provides a generally direct fluid path from proximal aspiration chamber 152 to user interface port 35, since hole 122 is vertically aligned with hole 136 of irrigation hub 64 and with the hole in collet 62 that defines user interface port 35 on an exterior of blade coupler 33.
  • aspiration control pathway 65 is not limited to particular arrangement shown in FIGS. 1-7B provided that a pathway extends from some portion of lumen 105 of inner member 50 (such as proximal vacuum window 103) internally within a distal portion of handpiece 32, a blade coupler 33, or similar structure to an exteriorly positioned user interface port (e.g., user interface port 35) accessible by the finger of a surgeon.
  • a pathway extends from some portion of lumen 105 of inner member 50 (such as proximal vacuum window 103) internally within a distal portion of handpiece 32, a blade coupler 33, or similar structure to an exteriorly positioned user interface port (e.g., user interface port 35) accessible by the finger of a surgeon.
  • aspiration control pathway 65 as part of aspiration control mechanism 34 defines an exclusively internal fluid pathway bridging a user interface port (i.e., an exterior opening of a handpiece or as part of a distal extension of the handpiece) to a larger fluid pathway 36 extending between a cutting implement 30 and a source of negative pressure 24.
  • the fluid pathway 36 further extends through the lumen 105 of the inner member 56 ( FIG. 3A , 4B , and 5-6 ), and is open at the aperture 168 ( FIG. 4B ).
  • the aspiration outlet at the cutting implement 30 can be provided in other forms that may or may not include the aperture 168 of the inner member 56 (e.g., aspiration can be provided via the outer member 52, via a separate tube provided with the blade assembly 28, etc.).
  • the aspiration control mechanism 34 affords the user the ability to control a level of vacuum applied at the cutting implement 30.
  • control over the aspiration delivered at the cutting implement 30 is selectively effectuated by covering or uncovering the user interface port 35.
  • a level or rate or vacuum delivered to or experienced at the aperture 168 ( FIG. 4B ), or other aspiration outlet configuration will increase as the user interface port 35 ( FIG. 1-3A ) is increasingly covered, and vice-versa.
  • the user interface port 35 has, in some configurations, a larger surface area as compared to the aspiration outlet provided at the cutting implement 30 through which suctioning is otherwise applied.
  • the aspiration outlet provided with the cutting implement 30 is the aperture 168 formed by the inner member 56 ( FIG. 3 ).
  • a size of the user interface port 35 can be selected to be greater than a size of the aperture 168.
  • a vacuum level at the cutting implement 30 i.e., at the aperture 168) is substantially zero in that the user interface port 35 provides a path of least resistance for negative pressure within the fluid pathway 36.
  • the size of the user interface port 35 can be increased even more to be substantially larger than size of the aperture 168 to insure the elimination of suction at the cutting implement 30.
  • a user will readily "sense" vacuum or suction at the user interface port 35, and is thus provided with direct, tactile feedback as to a level of vacuum being applied at the cutting implement 30.
  • the user interface port 35 affords essentially infinite control over the applied vacuum (between zero and maximum generated at the source of negative pressure 24) due to the absence of pre-established indexes or other stop mechanism along the aspiration control mechanism 34.
  • the user interface port 35 is embodied in a tear-drop shape (on an exterior of collet 62 of blade coupler 33) to yield user interface port 194, as shown in FIG. 7A .
  • the variable cross-sectional area presented by the tear-drop shape enables more precise control over the level of aspiration during finger control by the surgeon.
  • collet 62 is provided with a rotatable cover 185 configured to selectively cover the user interface port 194 (or user interface port 35 having a circular shape).
  • rotatable cover 185 enables the surgeon to block user interface port 194 for a period of time, in case it is desired to maintain closure of user interface port 194 (or user interface port 35) for an extended period of time. Later, the surgeon can simply rotate cover 185 away from user interface port 194 when it is desired to resume finger-controlled access to user interface port 194 (or a user interface 35 having a circular shape).
  • FIG. 7A Final construction of the blade assembly 28 is further shown in FIG. 7A .
  • the inner member 56 is received within the lumen 74 ( FIGS. 5-6 ) of the outer member 52, and is attached to the inner member hub 100.
  • the inner member hub 100 is positioned proximal the aspiration hub 60 and is rotatable relative thereto, such that rotation of the inner member hub 100 effectuates rotation of the inner member 56 relative to the outer member 52.
  • the cutting tip 102 of the inner member 56 is positioned at the cutting window 70 of the outer member 52.
  • the cutting tip 102 is exteriorly exposed via the cutting window 70 for performing a cutting or debriding procedure.
  • the distal region 66 of the outer member 52 combines with the cutting tip 102 to form the cutting implement 30.
  • Aspiration is effectuated at the cutting implement 30 via the aperture 168 provided with the inner member 56 (with the aperture 168 being exteriorly open through the cutting window 70).
  • aspiration or suctioning at the cutting implement 30 can be provided by the outer member 52, a separate tubing carried by the cutting implement 30, etc.
  • irrigation is provided at the cutting implement via the outer member 52/cutting window 70, although in other embodiments, an additional irrigation supply tube (carried with or separate from the cutting implement 30) can be provided.
  • the handpiece 32 and blade coupler 33 can assume a variety of forms that promote manipulation of the blade assembly 28/cutting implement 30 by a user, as well as powered movement of the inner member 56 relative to the outer member 52.
  • the optional control assembly 40 shown in FIG. 1 facilitates rotation of the outer member 52 relative to the inner member 56 as described below, and can assume a variety of forms.
  • the control assembly 40 comprises an actuator 190 including a rotatable finger controller 192 and a translation mechanism 194, which is configured to translate motion of actuator rotatable finger controller 192 into rotation of outer member 52.
  • the rotatable finger controller 192 can be akin to a wheel 41 as shown in FIG.1 , and is rotatably assembled to the housing 38 (or as represented by 200 in FIG.7B ).
  • the translation mechanism 194 is configured to translate rotation of the rotatable finger controller 192 to the aspiration hub 60, and thus to the outer member 52.
  • translation mechanism 194 includes features adapted to interface with the rotation-engaging mechanism 116 of the aspiration hub 60. More particularly, and as best shown in FIG. 7A , in some constructions, the rotation-engaging mechanism 116 of the aspiration hub 60 is a series of circumferentially disposed indentations 196. In one arrangement, translation mechanism 194 includes features configured to interface with the indentations 196, akin to a ball and detent relationship. With this configuration, then, rotation of the rotatable finger controller 192 (e.g. wheel 41 in FIG. 1 ) is translated via translation mechanism 194 to the aspiration hub 60. Rotation of the aspiration hub 60, in turn, rotates the outer member 52.
  • the rotation-engaging mechanism 116 of the aspiration hub 60 is a series of circumferentially disposed indentations 196.
  • translation mechanism 194 includes features configured to interface with the indentations 196, akin to a ball and detent relationship.
  • rotation of the aspiration hub 60 results in rotation of the outer member 52 relative to the inner member 56.
  • rotation of the outer member 52 can be achieved by a user without overt movement of the housing 38 of handpiece 32 in FIG. 1 (or housing 200 as schematically represented in FIG. 7B ). While grasping the housing 38 in his or her hand, the surgeon simply rotates the wheel 41 (represented schematically as rotatable finger controller 192 in FIG. 7A ) with a finger (or thumb) of the same hand that is otherwise holding the housing 38 of the handpiece 32 shown in FIG. 1 .
  • the handpiece 32 can assume a variety of forms that promote manipulation of the blade assembly 28/cutting implement 30 by a user, as well as powered movement of the inner member 56 relative to the outer member 52.
  • FIG. 7B illustrates one construction of the handpiece 32 in accordance with the principles of the present disclosure.
  • certain proximal portions of the aspiration control mechanism 34 FIG. 2
  • transition assembly 42 such as the details of translation mechanism 194
  • the handpiece 32 is shown in FIG. 8 as being assembled to components of blade coupler 33, including portions of the blade assembly 28.
  • the handpiece 32 includes a housing 200, the control assembly 40, a motor 202 (shown schematically in FIG. 7B ), and a drive coupling 204.
  • the motor 202 is secured within the housing 200, with the housing 200 forming a conduit 208 through which wiring (not shown) otherwise providing power to the motor 202 can extend.
  • the housing 200 preferably includes an output shaft 210 (which also defines a passage 214) and an aspiration port 39 for fluidly connecting the blade assembly 28 to the source of negative pressure 24 ( FIG. 1 ) as described below.
  • the drive coupling 204 mechanically connects the motor 202 to the inner member hub 100, and thus the inner member 56. To this end, a wide variety of constructions can be employed.
  • the drive coupling 204 includes the output shaft 210 which is rotatably linked (e.g., geared) to a drive shaft 212 of the motor 132.
  • the output shaft 210 can assume various forms, and with some constructions forms the passage 214 that, upon final assembly, fluidly connects the aspiration port 39 with a passageway 216 (see FIGS. 5-6 ) formed by the inner member hub 100 (and thus with the lumen 105 of the inner member 56 otherwise assembled to the passageway 216).
  • Optional dynamic seals 218 can be included to better ensure a fluid-tight seal between the passage 214 and the aspiration port 39.
  • the control assembly 40 can assume a variety of other forms apart from the description provided above, for example as described in U.S. Patent Application Serial No. 10/854,020 filed September 22, 2004 and entitled "Surgical Cutting Instrument". Conversely, with other constructions of the surgical instrument 22, the control assembly 40 is omitted (i.e., the outer member 52 cannot be independently rotated relative to the inner member 54). Where provided, however, rotation of the outer member 52 relative to the inner member 56 allows the user to selectively shield the cutting tip 102 from unintentionally contacting, and thus possibly damaging, delicate tissue of the brain and surrounding anatomy during a brain tumor debridement procedure. For example, as shown in FIG.
  • a rotational position of the outer member 52 relative to the inner member 56 can be selected such that the cutting tip 102 is exteriorly exposed at the cutting window 70. With this orientation, the cutting tip 102 can contact and cut tissue adjacent the cutting implement 30. Conversely, the outer member 52 can be rotated relative to the inner member 56 such that the cutting tip 102 is within the outer member 52, as shown in FIG. 8B . With this arrangement, then, the outer member 52 prevents the cutting tip 102 from contacting, and possibly damaging, tissue.
  • the outer member 52 can be rotated to position or "face" the cutting window 70 at a desired location (e.g., a brain tumor) without movement of the handpiece 32 ( FIG. 1 ) via the control assembly 40 ( FIG. 1 ). That is to say, once the cutting implement 30 is delivered to a treatment site, the precise location at which cutting will occur (i.e., the cutting window 70) can be controlled by movement of the control assembly 40 ( FIG. 1 ) (or as schematically represented by rotatable finger controller 192 in FIG. 7A ). Accordingly, the surgeon will not be forced to contort his or her hand(s) to achieve a desired point of cutting/position of the cutting window 70.
  • a desired location e.g., a brain tumor
  • treatment of a brain tumor 250 in accordance with aspects of the present disclosure includes forming an access opening in the patient's skull 252 (e.g., a conventional craniotomy).
  • FIG. 9A schematically illustrates other anatomy, including the dura 254, the arachnoid 256, the pia 258, and the cortex 260.
  • the brain tumor 250 is shown as projecting from a natural anatomy of the cortex 260, exteriorly "covered” by the pia 258.
  • the brain tumor 250 may be internal or embedded within the cortex (or other brain tissue) 260. Regardless, once a treatment site 262 at which the brain tumor 250 is located has been exposed, the system 20 is operated to remove at least some, preferably all, of the brain tumor 250.
  • the cutting implement 30 is deployed to the treatment site 262.
  • the power supply 26 ( FIG. 1 ) is inactive, such that the inner member 56 ( FIG. 3A ) does not move relative to the outer member 52 of blade assembly 28.
  • the source of negative pressure 24 ( FIG. 1 ) may or may not be activated during initial placement of the cutting implement 30. That is to say, a negative pressure condition may or may not be established along the fluid pathway 36. Where the source of negative pressure 24 is activated, however, the user manually effectuates control over delivery of negative pressure to the cutting implement 30, such as by leaving the user interface port 35 ( FIGS. 1-3A ) associated with the aspiration control mechanism 34 uncovered.
  • this arrangement causes virtually all of the negative pressure generated by the source of negative pressure 24 to be delivered to the user interface port 35, and thus not the aspiration outlet/aperture 168 of the cutting implement 30 in a manner that might otherwise negatively impact surrounding tissue of the treatment site 262.
  • the surgeon manipulates the handpiece 32 so as to position the elevator tip 72 (where provided) partially between the brain tumor 250 and surrounding tissue of the treatment site 262.
  • the control assembly 40 (including wheel 41 as shown in FIG. 1 ) can be operated by the surgeon to rotate the elevator tip 72 to a desired spatial orientation relative to the treatment site 262 without overt twisting/contortion of the surgeon's hand(s).
  • the elevator tip 72 is positioned between the brain tumor 250 and a portion of the pia mater 258.
  • the elevator tip 72 partially isolating the brain tumor 250 from this tissue.
  • the elevator tip 72 at least partially separates or isolates the brain tumor 250 from the surrounding tissue with the blade edge 84 ( FIG. 4A ) possibly partially severing a portion of the brain tumor 250 away from the surrounding tissue.
  • the blade edge 84 can be manipulated to pierce the pia 258 at a relatively precise location in close proximity to the tumor 250. Further, by controlling (minimizing) aspiration at the cutting implement, unnecessary damage to the pia 258 (and other tissue) is avoided.
  • the handpiece 32 can be further manipulated to cause the elevator tip 72 to pry the brain tumor 250 away from the surrounding tissue.
  • the cutting tip 102 (referenced generally in FIG. 7A ) is placed into contact with the brain tumor 250.
  • the outer member 52 is moved (e.g., rotated) such that the cutting window 70 "faces" the brain tumor 250.
  • the aspiration control mechanism 34 is manually operated to effectuate delivery of negative pressure to the cutting implement 30, thus drawing or suctioning the brain tumor 250 into contact with the cutting tip 102.
  • the surgeon can at least partially obstruct the user interface port 35 ( FIGS. 1-3A ), effectuating a more complete fluid connection between the source of negative pressure 24 and the aspiration aperture 168.
  • the surgeon can readily, visually confirm desired placement and orientation of the cutting implement 30, and in particular the elevator tip 72 and the cutting window 70/cutting tip 102, relative to the brain tumor 250 and the surrounding tissue.
  • the power supply 26 is activated, thus causing the inner member 56 ( FIG. 3 ) to move relative to the outer member 52.
  • This action causes the cutting tip 102 to move within the cutting window 70, cutting or debriding the contacted brain tumor 250.
  • the motor 202 FIG. 7B
  • the aspiration control mechanism 34 can be manually operated (e.g., movement of the surgeon's finger relative to the user interface port 35) to effectuate an increased vacuum level at the cutting implement 30, thus removing debrided brain tumor tissue from the treatment site 262.
  • the surgeon can periodically confirm continued desired positioning of the cutting implement 30 relative to the brain tumor 250 and the surrounding tissue 256.
  • the outer member 52 can be rotated relative to the inner member 56 ( FIG. 3 ), thereby altering a spatial position of the cutting window 70, and thus a point of contact of the cutting tip 102 with the brain tumor 250.
  • the wheel 41 of control assembly 40 shown in FIGS. 1-2 (and also represented by rotatable finger controller 192 shown in FIG. 7A ) can be manipulated by the user's finger, causing a rotational position of the outer member 52 relative to the inner member 56 to change.
  • the level of vacuum or rate of aspiration can be manually changed at any time by the surgeon, for example by simply covering more or less of the user interface port 35 ( FIGS. 1-7B ).
  • the surgical systems and methods of the present disclosure provide a marked improvement over previous surgical techniques.
  • the cutting implement including the distal cutting tip and optional elevator tip, can safely remove selected target tissue, but not damage the surrounding tissues. Further, with selective variable aspiration, the target tissue can be isolated from the surrounding tissue for subsequent removal and more aggressive cutting.
  • an aspiration control mechanism within a blade coupler (or directly within a handpiece), the handpiece is not encumbered with extraneous structure an exterior of the handpiece, thereby facilitating nimble handling of the handpiece by the surgeon as well providing convenient finger control over aspiration.
  • the ability to rotate the outer member assists in protecting any delicate surrounding tissue (e.g., dura, arachnoid, pia, etc.) such as when the cutting implement is used to treat brain tumors or to protect other delicate tissues (e.g., vocal cords, esophagus) when treating tumors or lesions in the airway.
  • delicate surrounding tissue e.g., dura, arachnoid, pia, etc.
  • other delicate tissues e.g., vocal cords, esophagus

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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EP09720711.2A 2008-03-07 2009-02-24 Systems for surgical removal of tissue Active EP2262432B1 (en)

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US12/044,644 US8109956B2 (en) 2008-03-07 2008-03-07 Systems and methods for surgical removal of tissue
PCT/US2009/034980 WO2009114259A1 (en) 2008-03-07 2009-02-24 Systems for surgical removal of tissue

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JP (1) JP5702606B2 (es)
CN (1) CN102006829B (es)
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JP5702606B2 (ja) 2015-04-15
EP2262432A1 (en) 2010-12-22
US20090228030A1 (en) 2009-09-10
ES2530721T3 (es) 2015-03-04
AU2009223387A1 (en) 2009-09-17
WO2009114259A1 (en) 2009-09-17
CA2716633C (en) 2016-08-02
AU2009223387B2 (en) 2014-02-27
JP2011514201A (ja) 2011-05-06
US8109956B2 (en) 2012-02-07
CN102006829B (zh) 2013-06-12
CA2716633A1 (en) 2009-09-17
CN102006829A (zh) 2011-04-06

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